Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
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DOI：
10.1038/bcj.2014.77
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发表时间：
2014-11-07
影响因子：
12.8
通讯作者：
Baz R
中科院分区：
文献类型：
--
作者：
Dimopoulos MA;Swern AS;Li JS;Hussein M;Weiss L;Nagarwala Y;Baz R
汇总了两项评估来那度胺和地塞米松联合治疗复发性/难治性多发性骨髓瘤（RRMM）的随机关键性III期试验的数据，以描述获得长期治疗获益（无进展生存期> 3年）的患者亚组。具有长期治疗获益的患者（n=45）的中位治疗持续时间为48.1个月，缓解率为100%。体液改善（不涉及免疫球蛋白A）在长期治疗获益的患者中更常见（79% vs 55% P=0.002）。多变量分析中治疗长期获益的显著预测因素为年龄<65岁（P=0.03）、β2-微球蛋白<2.5 mg/l（P=0.002）和既往治疗较少（P=0.002）。在长期治疗获益的患者中，3-4级中性粒细胞减少症的确诊调整发生率（EAIR）较低（13.9 vs 38.2/100患者-年）。浸润性第二原发恶性肿瘤的EAIR在具有长期治疗获益的患者和其他患者中相同（1.7/100患者-年）。这些结果表明，RRMM患者可以从来那度胺和地塞米松治疗中获得长期获益，副作用可控。
Data from two randomized pivotal, phase 3 trials evaluating the combination of lenalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM) were pooled to characterize the subset of patients who achieved long-term benefit of therapy (progression-free survival ⩾3 years). Patients with long-term benefit of therapy (n=45) had a median duration of treatment of 48.1 months and a response rate of 100%. Humoral improvement (uninvolved immunoglobulin A) was more common in patients with long-term benefit of therapy (79% vs 55% P=0.002). Significant predictors of long-term benefit of therapy in multivariate analysis were age<65 years (P=0.03), β2-microglobulin <2.5 mg/l (P=0.002) and fewer prior therapies (P=0.002). The exposure-adjusted incidence rate (EAIR) of grade 3–4 neutropenia was lower in patients with long-term benefit of therapy (13.9 vs 38.2 per 100 patient-years). The EAIR for invasive second primary malignancy was the same in patients with long-term benefit of therapy and other patients (1.7 per 100 patient-years). These findings indicate that patients with RRMM can experience long-term benefit with lenalidomide and dexamethasone treatment with manageable side effects.